Surgical stapler apparatus and method

ABSTRACT

A surgical stapler apparatus or assembly comprises a surgical stapler device having an internal channel extending from a stapler actuating handle to a stapler head of the device and a gas insufflation device having a pressurized gas supply connected to the internal channel of the stapler device via an inlet port at a handle portion intersecting with the channel in order to supply pressurized gas to the channel as the stapler shaft is inserted into the lumen of a colon, rectum or the like. Pressurized gas travels along the channel and out of the stapler head at the distal end of the stapler device in order to inflate the lumen ahead of the advancing stapler head, easing insertion.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/480,662, filed on Jul. 24, 2019, which is the U.S. national stage ofInternational Patent App. No. PCT/US2018/014529, filed on Jan. 19, 2018,which are all hereby incorporated herein by reference as if set forth infull.

BACKGROUND Related Field

The subject matter discussed herein relates generally to surgicalanastomosis equipment and methods, and particularly to surgical staplersused primarily for gastrointestinal anastomoses as a part of intestinalsurgery.

Related Background

End-to-end anastomosis staplers, also known as EEA staplers, are usedfor stapling together generally circular end portions of the rectum,colon, small bowel, stomach and esophagus following surgery. Suchdevices have handles including a staple actuator and an elongatedstapler shaft extending from the handle and designed to be insertedthrough the lumen of the organ which is to be stapled. The distal end ofthe EEA stapler has a stapler head or cartridge and an anvil movablerelative to the head between an advanced position spaced from the headand a retracted, stapling position in which opposing, generally annular,cut end portions of the organ to be stapled are gripped between opposingend faces of the head and anvil. The anvil is secured at the end of aretractable anvil stem. After insertion of the stapler shaft into therectum, colon or the like and retraction in to the gripping positionready for stapling once the end portions of the cut organ are suitablysecured to the head and anvil, respectively, and actuator in the handleis activated to fire the stapler head to secure end portions of therectum, colon or the like together with a circle of staples.

Trans rectal introduction of such staplers can sometimes provechallenging given the presence of rectal valves that can sometimesimpede introduction of the stapler to the required location,particularly if the rectum needs to be traversed. The design of thestapler itself can add to this problem since it has sharp angles at thestapler end portion which needs to be introduced. In some cases,surgeons use graduated dilating instruments which are sequentiallyintroduced trans-rectally in progressively larger sizes to stretch openthe rectal valves prior to introducing the stapler. This furtherincreases the time required for the procedure.

SUMMARY

In one embodiment, a surgical stapler apparatus has a handle portionincluding a staple actuator, an elongate portion extending from thehandle portion and designed to be inserted through the lumen of theorgan which is to be stapled, a stapler head at a distal end of theelongate portion and an anvil movably mounted at the stapler head andmovable relative to the head between an advanced condition spaced fromthe head and a retracted, stapling position configured to grip endportions of a lumen to be stapled, the handle portion having a gas orair inlet port in communication with an internal channel extending fromthe handle portion to the stapler head, and an air insufflation devicecomprising a gas supply tube having a first end in sealing engagementwith the inlet port in the handle portion and a supply of pressurizedgas or air in communication with the gas supply tube. The supply ofpressurized gas or air may comprise a manually operated inflation bulbor pump or a pressurized gas supply which does not require manualpumping.

In one embodiment, an existing surgical stapler apparatus is retrofittedto add the gas supply inlet port in communication with the existingstapler channel. No modification to the stapler shaft or channel itselfis required, other than the addition of the gas inlet port extendingtransversely through the wall of the handle portion to intersect thechannel or lumen extending from the handle to the stapler head of theapparatus. An on-off valve at the inlet port may be provided to openautomatically in response to gas pressure and to close when thepressurized gas supply is stopped or disconnected.

The air insufflation device attached to the proximal or handle end ofthe stapler apparatus allows air to be introduced through the channel ofthe stapler shaft up to the distal end, where it exits through the endof the stapler head or stapler base. The pressurized gas blown into therectal lumen stretches the rectum and rectal valves open, reducing therisk of impeding introduction of the stapler shaft to the desiredlocation or of sharp angles at the stapler head being hung up or snaggedby the rectal valves, and generally allowing for smoother introductionof the stapler head and shaft along the rectum or other passageway. Thismay avoid the need to use gradual dilating instruments to open thepassage in advance of introduction of the stapler.

Since the air inflation device uses the existing passageway or channelalong the stapler shaft for introducing pressurized air into the lumenof the rectum or other abdominal organ, there is no need to modify theinternal design of the stapler itself to allow for air insufflation.Thus, the air insufflation device may be readily retro-fitted onto apre-existing EEA stapler, by drilling an air insufflation port into thehandle end portion of the pre-existing stapler and attaching theexternal tubing with the manual bulb pump or other pressurized airsource.

According to another aspect, the integrity of an anastomosis of thecolon or rectum after firing the stapler may be tested by supplyingpressurized air to the stapler shaft channel from the pressurized airsupply via the supply tube. If no air bubbles are seen at theanastomosis site, then the anastomosis may be considered intact. Apressure relief valve may be provided in the insufflator air supply tubeand configured to cut off supply of gas to the stapler channel if theair pressure exceeds a predetermined maximum value, such as 25 mm. Hg,so as to avoid or reduce the risk of over-inflation of the rectum orcolon, which may otherwise result in tearing the staple line at the endof the rectum.

BRIEF DESCRIPTION OF THE DRAWINGS

The details of various embodiments can be gleaned in part from a studyof the accompanying drawings, in which like reference numbers refer tolike parts, and in which:

FIG. 1 is a perspective view illustrating one embodiment of ananastomosis surgical stapler apparatus including an air insufflationdevice;

FIG. 2 is a perspective, cut-away view of the handle portion of theapparatus of FIG. 1 ;

FIG. 3 is a longitudinal cross-sectional view of part of the handle ofthe stapler apparatus, illustrating the connection of air supply tube toan inlet port connected to the existing stapler channel;

FIG. 4 is a perspective view of the stapler head of FIG. 1 in anextended condition in which the anvil and anvil stem or shaft of thestapler extend out of the stapler base; and

FIG. 5 is an end view of the stapler base illustrating the exit end ofthe passageway or channel through which gas is blown into the rectum inadvance of the stapler apparatus.

DETAILED DESCRIPTION

Certain embodiments as described herein are generally concerned withend-to-end anastomosis staplers for use in gastrointestinal surgery, andprovide for a circular, end-to-end stapler apparatus including aninsufflation device having a pressurized gas supply and a gas or airhose extending from the gas supply and secured to an inlet port at oradjacent the handle portion of the stapler apparatus in communicationwith an existing channel extending from the handle portion through thestapler shaft to the stapler head, to allow for insufflating the rectum,colon or like with air in advance of the stapler head during insertionof the stapler shaft to a stapling location.

The subject matter described herein is taught by way of exampleimplementations. Various details have been omitted for the sake ofclarity and to avoid obscuring the subject matter. The examples shownbelow are directed to devices, systems and methods for providing acombined surgical stapler and gas insufflator apparatus. Features andadvantages of the subject matter should be apparent from the followingdescription.

After reading this description it will become apparent to one skilled inthe art how to implement the invention in various alternativeembodiments and alternative applications. However, all the variousembodiments of the present invention will not be described herein. It isunderstood that the embodiments presented here are presented by way ofan example only, and not limitation.

FIGS. 1 to 5 illustrate one embodiment of a combined surgical staplerand gas insufflator apparatus or assembly 10 which comprises anend-to-end anastomosis or EEA stapler device 12 and an insufflationdevice comprising a pressurized air or gas supply 14 and an air inputtube 28 connected between gas supply 14 and a gas supply inlet port 15at the handle portion 16 of stapler device 12. The EEA stapler device 12may be any conventional EEA stapler having an interior channel extendingfrom the handle to the stapler head assembly, such as the EthiconEndosurgery ILS™ 25 manufactured by Ethicon, Inc. of Somerville, N.J.,or other similar devices, and therefore will not be described in detail.

Stapler shaft 18 extends from handle portion 16 up to stapler headassembly 20 at the distal end of the shaft. As is known in the field,stapler shaft 18 is designed to be inserted through the lumen of theorgan which is to be stapled. Stapler head assembly 20 has a staplerhead base 22 including a circular staple cartridge with openings 23 inan end wall of the base (see FIG. 5 ) and an anvil 24. Anvil 24 has ananvil shaft 25 which is extendable from the shaft 18 via an actuator inthe handle between an advanced position (see FIG. 4 ) spaced from thehead in which the anvil engages in an aligned end of the lumen of anorgan such as the rectum or colon after surgery, and a retracted,stapling position as in FIG. 1 in which it is configured to grip endportions of a lumen to be stapled between the stapler base and anvil. Astapler actuation channel or passageway 26 extends from the handleportion up to the stapler base 22, and part of channel 26 is located inthe handle as seen in FIG. 3 . Gas supply inlet port 15 intersects withchannel 26 in the vicinity of the actuator or trigger 30 of the handle,as seen in FIGS. 1 to 3 . Apart from the intersection with inlet port15, channel or passageway 26 is otherwise identical to stapler actuationpassageways as known in the field. In one embodiment where an existingstapler device is retrofitted to include the pressurized gas supply,port 15 is formed by drilling a hole at a suitable location in the wallor shaft of handle 16 up to channel 26.

Gas supply tube 28 has an outlet end secured to the port 15 in handle16. As illustrated in FIG. 3 , a rubber sealing gasket or nipple 35 maybe mounted on the end of tube 28 or in port 15 for sealing engagementbetween the tube and port to prevent or reduce the risk of gas leaks. Nomodification to the stapler shaft or channel itself is required, otherthan the addition of a gas inlet port in the wall of the handle portionfor connection to the air supply hose. Thus, any existing EEA staplerdevice can be easily retrofitted to incorporate the air insufflatordevice, without requiring any modification to the internal design of thestapler shaft.

A conventional spring-loaded on-off valve (not illustrated) may belocated at the inlet port in some embodiments, with the valve configuredto open automatically in response to gas pressure and to close when thepressurized gas supply is stopped or disconnected. A pressure reliefvalve 34 may also be provided in the gas supply hose and configured tocut off supply of gas to the stapler channel if the air pressure exceedsa predetermined maximum value, such as 25 mm. Hg, so as to avoid orreduce the risk of excessive inflation of the rectum or colon, which mayotherwise result in tearing the staple line at the end of the rectum. Insome embodiments, the air or gas supply 14 may be selectively connectedto port 15 by a Luer-type connector 29 or the like (see FIG. 2 ).

Any suitable pressurized air or gas supply device may be used, such asthe manually operated air pump bulb 14 illustrated in FIG. 2 . Inalternative embodiments, bulb 14 may be replaced with other types ofmanually or automatically operated medical air or gas pumps, or tanks ofpressurized gas.

The air insufflation device attached to the proximal or handle end ofthe stapler apparatus allows air to be introduced through the channel ofthe stapler shaft up to the distal end, where it exits via the staplerhead openings. This stretches the rectum and rectal valves open,reducing the risk of impeding introduction of the stapler shaft to thedesired location and the risk of sharp angles of the stapler head beinghung up or snagged by the rectal valves, and generally allowing forsmoother introduction of the stapler head and shaft along the rectum orother passageway. This may avoid the need to use gradual dilatinginstruments to open the passage in advance of introduction of thestapler.

In one embodiment, pressurized gas is supplied from the insufflationdevice to the existing stapler channel as the stapler shaft is advancedto the desired stapling site, so that air is blown into the rectum orcolon while the stapler head is being positioned. Once the stapler isfired, air is again blown through the channel and out of the staplerhead to test the anastomosis. Lack of any observed bubbles in the bloodand fluids around the site indicates integrity of the anastomosis.

The insufflation device described above can be readily retrofitted ontoany existing surgical stapler without any need to re-design the interiorpassageway or channel of the stapler or run any additional componentssuch as air tubes along the length of the stapler. All that is requiredis to drill an air or gas inlet port transversely through the handleportion until it intersects with an existing stapler channel extendingthrough the stapler head. In other embodiments, the surgical staplerdevice may be manufactured with a built in-insufflation device which mayhave a gas supply tube permanently or removably attached to the handleportion of the stapler to supply pressurized gas or air to the internalchannel.

The above description of the disclosed embodiments is provided to enableany person skilled in the art to make or use the invention. Variousmodifications to these embodiments will be readily apparent to thoseskilled in the art, and the generic principles described herein can beapplied to other embodiments without departing from the spirit or scopeof the invention. Thus, it is to be understood that the description anddrawings presented herein represent a presently preferred embodiment ofthe invention and are therefore representative of the subject matterwhich is broadly contemplated by the present invention. It is furtherunderstood that the scope of the present invention fully encompassesother embodiments that may become obvious to those skilled in the artand that the scope of the present invention is accordingly limited bynothing other than the appended claims.

What is claimed is:
 1. A method of retrofitting a surgical staplerapparatus to provide a pressurized gas supply to an internal channelextending from the handle to the stapler head of the surgical staplerapparatus, comprising: drilling an inlet port transversely through awall of a handle portion of a surgical stapler apparatus to intersectwith an internal channel extending along the length of the surgicalstapler apparatus up to the stapler head; and sealably connecting anoutlet end portion of a gas supply tube connected to a supply ofpressurized gas to the inlet port; whereby pressurized gas is suppliedthrough the gas supply tube and inlet port to the existing internalchannel of the stapler apparatus and exits the channel at the staplerhead to provide gas insufflation and dilation of a lumen of an abdominalorgan into which the stapler shaft is inserted.
 2. A method ofperforming a surgical stapling procedure using a surgical staplerapparatus, comprising: inserting a stapler head and shaft of a surgicalstapler apparatus into a lumen of an abdominal organ while supplyingpressurized gas into a channel extending axially along the stapler shaftvia a gas inlet in the handle end of the shaft to blow gas continuouslythrough the shaft and out of the distal end of the shaft into the lumenas the stapler head and shaft is inserted; continuing to supplypressurized gas along the channel and out of the distal end of the shaftuntil the stapler head reaches a surgical site for stapling; turning offthe supply of pressurized gas when the surgical site is reached; firingthe stapler head to secure tissue at the surgical site; after firing thestapler head, supplying pressurized gas into the channel to blow gas outof the distal end of the shaft at the surgical site; and observingliquid and blood at the surgical site while air is blown out of thedistal end of the shaft, whereby visible bubbles in fluid at thesurgical site provide an indication of lack of integrity of ananastomosis at the surgical site.
 3. The method of claim 1, wherein theinternal channel comprises a stapler actuator channel.
 4. The method ofclaim 1, wherein the surgical stapler further comprises an elongatedshaft extending from the handle portion to the staple head, theelongated shaft having an inside wall surface and an outside wallsurface, and wherein the internal channel is defined by the inside wallsurface of the elongated shaft.
 5. The method of claim 1, wherein thestep of drilling the inlet port comprises drilling through a wall of theinternal channel in order to intersect with the internal channel.
 6. Themethod of claim 2, wherein the channel comprises a staple actuatorchannel.